MedTrace Logo

Thiazolidinedione Intervention With Vitamin D Evaluation

NCT00879970 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1332

Last updated 2017-04-18

Study results available
· View outcomes & findings →

Summary

This study will answer two separate questions.

The first question is to test the cardiovascular effects of long-term treatment with rosiglitazone or pioglitazone when used as part of standard of care compared to similar standard of care without rosiglitazone or pioglitazone in patients with type 2 diabetes who have a history of or are at risk for cardiovascular disease.

The second question will compare the effects of long-term supplementation of vitamin D on death and cancer

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

pioglitazone

Pioglitazone30 mg and 45 mg tablets are over-encapsulated with Swedish orange size DB-AA capsule shell.

DRUG

rosiglitazone

Rosiglitazone 4 mg and 8 mg tablets are over-encapsulated with Swedish orange size DB-AA capsule shell.

DRUG

placebo

Placebo to match is Swedish orange size DB-AA capsule filled with white to off-white non-active powder blend.

DIETARY_SUPPLEMENT

Vitamin D

Vitamin D factor intervention

DIETARY_SUPPLEMENT

Placebo

Vitamin D factor intervention

Sponsors & Collaborators

  • Population Health Research Institute

    collaborator OTHER

  • GlaxoSmithKline

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • United States
  • Argentina
  • Canada
  • Chile
  • Colombia
  • Czechia
  • Denmark
  • Finland
  • Germany
  • India
  • Italy
  • Latvia
  • Mexico
  • Netherlands
  • Norway
  • Pakistan
  • Peru
  • Philippines
  • Romania
  • Russia
  • Slovakia
  • South Africa
  • Sweden
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00879970 on ClinicalTrials.gov